July 2014 FDA Recall Drug by Wockhardt Usa Inc.
D-1513-2014 - Failed Impurities/Degradation Products

This Class III drug recall was voluntarily initiated by Wockhardt Usa Inc. on July 14, 2014 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1513-2014

Reason for Recall
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Initiated
07-14-2014
Reported
08-13-2014
Quantity
840 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68813
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wockhardt Usa Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-12-2015
Product Description About Product Description
Full technical description of the product.
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07.

Batch or Lot Expiration Information

Lot# : DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14